Safety and Tolerability of LDRT+Sugemalimab+Chemotherapy+Olaparib for First-Line Treatment of SLF… (NCT06217757) | Clinical Trial Compass
RecruitingPhase 1/2
Safety and Tolerability of LDRT+Sugemalimab+Chemotherapy+Olaparib for First-Line Treatment of SLFN-11 Positive ES-SCLC
China45 participantsStarted 2024-04-18
Plain-language summary
The purpose of this study was to evaluate the safety and efficacy of low-dose radiotherapy (LDRT) combined with sugemalimab, olaparib, chemotherapy in the first-line treatment of SLFN-11 positive extensive stage small cell lung cancer.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Men or women aged more than or equal to (≥) 18 years old and less than or equal to (≤) 75 years old
✓. Histologically or cytologically confirmed ES-SCLC
✓. No prior treatment for ES-SCLC
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
✓. Five white slides (unstained paraffin sections) were available for immunohistochemical SLFN-11 detection and SLFN-11 was positive
✓. Extensive clinical stage. American Joint Committee on Cancer (AJCC) 8th edition Stage IV with lesions exceeding one side of the chest and including malignant pleural and pericardial effusions or hematogenous metastases (any T, any N, M1a/b/c); or T3-4 due to multiple nodules in the lung or tumor/nodule size too large to be included in a T3-4 disease within a tolerable radiotherapy schedule
✓. The subjects were considered suitable for combining etoposide with cisplatin chemotherapy and low-dose radiotherapy as first-line treatment for extensive -stage small cell lung cancer
✓. Have measurable lesions as defined by RECIST1.1, with at least one lesion (never previously treated with radiation) of ≥10 mm longest diameter accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI) at baseline (except for lymph nodes, which must have a short axis of ≥15 mm) and the lesion is suitable for repeat and accurate measurements
Exclusion criteria
✕. Histopathologic or cytopathologic diagnosis of mixed small cell lung cancer or non-small cell lung cancer
✕. Combination of poorly controlled malignant pleural or pericardial effusions requiring continuous drainage
✕. Presence of active or symptomatic brain metastases or Leptomeningeal metastases
✕. Prior systemic antitumor therapy (chemotherapy, targeted agents such as PARP inhibitors) or immune checkpoint inhibitors for SCLC
✕. Presence of active, unstable systemic disease such as active infection, autoimmune disease, inflammatory disease (uncontrolled hypertension, heart failure (NYHA classification \>= Class II), unstable angina, acute coronary syndrome, severe arrhythmia, severe hepatic, renal or metabolic disease, human immunodeficiency virus (HIV) immunodeficiency virus (HIV) infected patients
✕. Previous allogeneic stem cell or solid organ transplantation
✕. Patients with prior interstitial lung disease, drug-induced interstitial lung disease, or active interstitial pneumonia requiring systemic glucocorticoid or immunosuppressive therapy; Patients with pulmonary interstitial fibrosis or active pulmonary tuberculosis